BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUIDANT 4.5 MM HEARTSTRING PROXIMAL SEAL

    MDR report key: 603798 · Received May 9, 2005

    Report

    Report Number
    2953148-2005-00299
    Event Type
    Malfunction
    Date Received
    May 9, 2005
    Report Date
    May 3, 2005
    Manufacturer
    GUIDANT CARDIAC SURGERY
    Product Code
    DXC
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING THE CORONARY ARTERY BYPASS PROCEDURE, THE HEARTSTRING SEA DID NOT DEPLOY OUT OF THE DELIVERY TUBE INTO THE ACORTA. A REPLACEMENT WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED BY THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUIDANT 4.5 MM HEARTSTRING PROXIMAL SEAL VASCULAR CLAMP DXC GUIDANT CARDIAC SURGERY HS-1045 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA